1. Field of the Invention
The present invention generally relates to a tissue sampling mechanism for use as a diagnostic tool. More particularly, the present invention relates to a tissue sampling mechanism primarily designed for use in biopsy procedures, which tissue sampling mechanism is designed to collect relatively larger tissue samples as compared to state of the art tissue collection devices.
2. Discussion of the Prior Art
Many physicians in many specialties need to determine if tissues seen on imaging studies are normal or abnormal. Abnormal tissue can be cancerous and therefor later require surgical removal, chemotherapy or radiation therapy. One common or traditional method for determining whether tissue is abnormal is to do a needle biopsy. A needle biopsy is advantageous because it has few complications and does not require surgery or anesthesia. For example, if an abnormal area or abnormal calcification is seen on a mammogram, a needle biopsy of the abnormality is commonly performed. The tissue sample obtained from the needle biopsy can then be analyzed to determine and/or confirm whether the tissue is abnormal.
Some of the prior art relating to biopsy needles and other similar surgical or medical tools for securing samples of tissue or matter and the like are briefly described hereinafter. U.S. Pat. No. 2,137,710 ('710 patent), which issued to Anderson, for example, discloses certain Forceps. The '710 patent describes certain forceps comprising a tubular body, a single length of wire bent midway between its ends and located in said tubular body. The wire forms fingers which cross each other near their free ends and near the bent portion of said wire within said tubular body.
The forceps further comprise actuating means connected to the bent portion of said wire and movable relatively to the tubular body for extending said fingers beyond the mouth of the tubular body in divergent, quickly spreading arcuate directions. From a comparative inspection of FIGS. 1 and 2 of the '710 patent, it will be seen that tissue sampling ends 19 and 20 of fingers 14 and 15 selectively protrude from and retract into the tube 10 for grabbing tissues and the like.
U.S. Pat. No. 2,670,519 ('519 patent), which issued to Recklitis, discloses a Drainage Tube with Clot Extractor. The '519 patent essentially describes an embalming implement comprising an outer tube formed with a lateral opening in one end portion, an inner tube slidably and rotatably fitted within the outer tube and formed with a lateral opening alignable with the lateral opening in the outer tube, the end of the inner tube adjacent its lateral opening being closed and it other end being open, and a plurality of resilient prongs on the other end of the inner tube constructed and arranged to be received within the outer tube and to project in expanded relation beyond the outer tube when said lateral openings are aligned. From a comparative inspection of FIGS. 1 and 3 of the '519 patent, it will be seen that clot-grabbing ends 38 selectively protrude from and retract into the tube 10 for grabbing clots and the like.
U.S. Pat. No. 4,174,715 ('715 patent), which issued to Hasson, discloses certain Multi-Pronged Laparoscopy Forceps. The '715 patent describes multi-pronged spring-loaded laparoscopy instruments are provided for use in tubal sterilization, ovarian mobilization and biopsy. The instruments include three or four expandable prongs for holding tissue in a stable position. The instrument may be provided with a plug for access to an inner biopsy channel or central bore for facilitating ovarian biopsy.
A slotted bushing may be provided with offset apertures to enable the surgeon to hold the prongs in preselected positions without exerting pressure on the handle of the instrument. When desired, the instrument may be provided with a manually remote-controlled cutting edge at the forward tip of the instrument to re-sect a segment of the coagulated tube during tubal sterilization.
Referencing Column No. 5, Line Nos. 25-36, you will please note that the '715 patent further describes that the four-pronged laparoscopy forceps may also be used as a surgical cutting blade. The forwardmost circular edge of outer tube 29 being razor sharpened may be extended or retracted along tubular sleeve 26 by rotating collar 45. As the collar rotates, the stud 47 follows the spiral groove in guide sleeve 25 to translate the collar and the outer tube on the tubular sleeve. When the collar is rotated to its forwardmost position, the sharpened circular edge extends beyond the prongs. The diameter of tube 29, however, does not expand.
U.S. Pat. No. 4,427,014 ('014 patent), which issued to Bel et al., discloses Biopsy Forceps. The '014 patent describes biopsy forceps for use with a contact endoscope having a body terminating in a distal end comprising a hollow outer tube open at both ends, a hollow inner tube located coaxially within the outer tube, the inner tube being open at its rear end and terminating at its front end in at least one pair of diametrically opposed tongues that extend outwardly beyond the front end of the outer tube and in a direction substantially parallel to the longitudinal axis of the tubes and then bend inwardly at their far end at right angles to the longitudinal axis terminating in a series of teeth to form forceps jaws.
The jaws are biased in a direction away from the axis, whereby movement of the tubes in one direction relative to one another causes the tongues of the jaws to slide into the outer tube and the forceps jaws to close and movement in the opposite direction causes the jaws to open, and a control device for axially moving one of the tubes relative to the other to activate the jaws, whereby the endo scope can be inserted all the way through the forceps from its rear end so that the distal end of the endoscope lies against the forceps jaws.
U.S. Pat. No. 5,759,187 ('187 patent), which issued to Nakao et al., discloses certain Surgical Retrieval Assembly and Associated Method. The '187 patent describes a method for removing a polyp from a patient utilizes (i) a flexible conductive cauterization loop and (ii) a flexible auxiliary loop to which a flexible web member is connected to define an expandable pocket, the cauterization loop and the auxiliary loop being disposed in a common tubular member. Upon insertion of an endoscope assembly into a patient and a locating of the polyp, the tubular member is moved through the biopsy channel of the endoscope to eject a distal end portion of the tubular member from the biopsy channel.
The cauterization loop is then shifted in a distal direction relative to the ejected tubular member to eject the cauterization loop from the tubular member. The cauterization loop is manipulated from outside of the patient to pass the loop over the polyp and to at least partially close the loop to engage the polyp around a base region thereof.
Upon a subsequent conducting of an electrical current through the cauterization loop to burn through the polyp at the base region, thereby severing the polyp at the base region, the cauterization loop is retracted into the tubular member and the auxiliary loop is ejected and maneuvered to enclose the severed polyp in the capture pocket. The auxiliary loop is at least partially closed to capture the severed internal body tissues in the pocket. The captured polyp is removed in the pocket from the patient.
U.S. Pat. No. 6,273,860 ('860 patent), which issued to Kostylev et al., discloses a Biopsy Apparatus. The '860 patent describes an endoscopic instrument having one or two moving jaws. One or two control wires attach to the lower portion of the moving jaws. Each control wire is located within a groove or enclosed channel which passes along the side and preferably to the back of the jaw.
The end of the control wire is connected with the jaw so that when the control wire is moved, the force from the wire moved the jaw about its pivot point. If two moving jaws are present, the pivot point is preferably centrally located in the housing. If only a single moving jaw is used, the pivot point may be central, or it may be offset. The control wire is arguably similar to a pull cord insofar as it operates to direct a pulling force to the mechanism it operates.
In this last regard, U.S. Pat. No. 6,569,105 ('105 patent) is also pertinent. The '105 patent, which issued to Kortenbach et al, discloses Method Rotatable and Deflectable Biopsy Forceps. The '105 patent describes an endoscopic or laparoscopic biopsy forceps instrument is provided which includes a flexible tubular member having proximal and distal ends, a biopsy jaw assembly at the distal end of the tubular member, an actuation assembly to operate the jaw assembly between open and closed positions, and a control assembly to deflect the biopsy jaw assembly relative to a lumen through which the instrument extends and to rotate the jaw assembly about the longitudinal axis of the instrument.
U.S. Pat. No. 8,226,575 ('575 patent), which issued to Levy, discloses Biopsy Needle Assemblies. The '575 patent provides needle biopsy systems and methods for obtaining tissue biopsies. In various embodiments, the systems and methods provided can inhibit needle contamination by unwanted tissue or cells and/or regulate a negative pressure to assist sampling of target tissue or cells. The reader may wish to reference FIG. 34, which figures depict a biopsy needle having a tissue sampling mechanism in a deployed position relative to the needle body.
United States Patent Application No. 2006/0178699, which was authored by Surd, describes biopsy forceps and method(s) of using the biopsy forceps. The biopsy forceps includes a plurality of grasping members extending from an inner shaft. The plurality of grasping members is biased toward an open configuration. Sliding a sheath over the grasping members constrains the grasping members to a closed configuration. The reader will note that the ends of the grasping members may be outfitted with blades as referenced at 33.
United States Patent Application No 2009/0227892, which was authored by Krombach et al., describes a catheter device for percutaneous interventions, in particular for injections, biopsies or the like, with an outer catheter and with a tool for the intervention, in particular an injection needle, biopsy forceps, electrodes or the like, at the proximal end of the catheter device.
To be able to perform a percutaneous intervention free of injury, the tool is received in the outer catheter in the delivery state, and the tip of the tool is recessed in the outer catheter in the delivery state or aligned with the proximal end of the outer catheter, and the tool can be moved relative to the outer catheter in such a way that at least the tip of the tool protrudes past the proximal end of the outer catheter in the state of engagement.
United States Patent Application No. 2010/0228221, authored by Kassab, describes devices, systems, and methods for accessing tissue in a minimally invasive manner and taking a biopsy tissue sample. At least some of the embodiments disclosed herein enable a tissue sample to be taken from the external surface of the heart in a non-invasive manner. In addition, various disclosed embodiments provide devices, systems and methods for accessing the pericardial space through the interior of the heart and engaging the epicardial surface and removing a tissue sample therefrom for diagnostic purposes through the use of suction. The reader may wish to reference FIGS. 16(a)-18(b) which references a collapsible skirt, which skirt does not appear to provide any cutting function.
From a consideration of the foregoing art particularly and the field of art generally, it will be seen that the prior art perceives a need for a tissue sampling mechanism that provides an expandable skirt-like structure, which when expanded defines a volumetric tissue sample-securing space and a planar circular cutting terminus for cutting into the tissue sample to be or secured. Further, the prior art perceives a need for such a device wherein the circular cutting terminus is cinchable for further cutting and enclosing the tissue sample to be secured within the skirt-like structure. Accordingly, the present invention provides such a mechanism, as summarized in more detail hereinafter.